The Temporo-spatial Dynamics of Genital Tract Microbiota - an Observational Study in Oocyte Donors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Rate of ascending infection/sharing of bacteria in the genital tract
研究概览
简要总结
The investigators aim to examine the endometrium with state of the art sequencing techniques to investigate the endometrial microbiota. The endometrial microbiota has been perceived to be sterile, however, this seems incorrect from recent studies. Thus, the primary outcome is to compare the rate of ascending infection from the vagina to the endometrium and to investigate which bacteria are capable of inhabiting these environments in healthy oocyte donors. These results will be compared to equivalent samples of IVF patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Oocyte donors meeting local criteria for donation. Written informed consent. Regular cycle
排除标准
- •Antibiotics within 1 month Vaginal products other than for menstrual hygiene within 1 month Uterine malformations(Septum, polyps, adenomyosis, fibroids) HIV, Hepatitis B or C positivity. HPV CIN 2 or higher. Chlamydia trachomatis positivity.
- •Any uncontrolled concomitant disease (e.g. uncontrolled diabetes, uncontrolled hypertension etc.)
结局指标
主要结局
Rate of ascending infection/sharing of bacteria in the genital tract
时间窗: This outcome data is measured at the 1 day of oocyte retrieval.
vaginal, cervical and endometrial samples will be compared at the time of oocyte retrieval.
次要结局
- Next generation sequencing techniques and qPCR will be used to assess the microbiota.I.e. measure of relative abundances and absolute abundances(This outcome data is measured at the 1 day of oocyte retrieval.)
研究者
Peter Humaidan
Professor, Consultant
Regionshospitalet Viborg, Skive